What does it take to make a difference?

** This is an editorial I wrote about 2005. So some of the numbers in it may be outdated. That does not mean they have changed for the better. I am reflecting on this today as after much thought I relize how little has changed, although there have been a few bright spots. If anyone wanted to know why OCF came into being, and wanted to understand what we have improved or changed, a look at the world in which we started is in order.

What does it take?

One person’s opinion.

By Brian Hill

This year cancer replaced heart disease as the number one killer of Americans. Since the official war on cancer was declared by President Nixon in 1972, progress has been made, but clearly not enough. Huge leaps in knowledge such as the mapping of the human genome, which we thought would yield the clues to scientific breakthroughs, have instead left us with the knowledge that cancer is not just a couple of pathology types, but literally hundreds of unique diseases. The more we find out, it is clearer the less we know. That does not mean that progress has not been made, just not progress that has yielded the breakthrough that will finally label cancer a manageable and survivable disease. To put this in perspective, the annual budget for cancer research in the US alone is over 5 billion dollars per year (requests of an additional 4.2 billion over the next 5 years were made this year by the NCI), in spite of this enormous expenditure and effort, one person dies of cancer every minute of every day in the US… and the disease has moved into first place.

While we continue to explore and digest the reams of new data that research is producing daily, we must look to those strategies that in the past have yielded the best immediate, tangible results. If you look at those cancers in which there have been palpable gains against the death rate, i.e. cervical, prostate, colon, etc., they all share two things in common. The first is that they have lent themselves to modes of early detection, even if that detection method is somewhat invasive such as a colonoscopy. This example in itself indicates that Americans will become engaged in early detection if public literacy and awareness are made an important part of the process. The “Katie Couric effect” in the rise of colon exams is clear evidence. They will submit to annual exams like cervical, if they believe that the benefits of opportunistic screening when they are asymptomatic, hold hope of increased survival should they be found with it. The second thing shared by all these cancers where progress can be documented is that in their early stages, they respond well to existing, conventional treatment modalities; surgery, radiation, and chemotherapy. What this clearly tells us, is that while science works on ultimate solutions, there are existing, viable mechanisms to reduce the deadly toll of cancer deaths in the US, and the proven vehicles are public awareness and early detection.

Just to pick one of these, cervical cancer, without the development of new science, but with only the adoption of an opportunistic annual screening by female members of the American population, saw during a 10 year period a drop of approximately 70% in its death rate. This is extraordinary by anyone’s standards. A motivated and informed public, serviced by a community of medical practitioners engaged in early detection yielded these results. Remember that this is an examination, which is essentially visual, tactile, and if suspect areas are found, a biopsy of those tissues is performed. I could be just as easily describing an oral cancer examination here. No difference exists.

Now the part that I find the most telling. There was no landmark study that said this would be the outcome, no study before adoption of cervical cancer screening that concluded this unprecedented saving of lives would be so dramatic. There have been many retrospective reviews of this situation, but in the late 40’s and 50’s the American public, the government, private professional medical societies, and doctors drew from what they knew to be sound clinical experience to initiate this program which has saved untold thousands of lives to date.

Just what is that clinical experience that I refer to? Essentially two things, and they have not changed in the subsequent decades. First, the knowledge that discovery of a disease in its early progression (early staging) yields better long-term outcomes. This is not rocket science. Before a cancer has had the opportunity to spread from a localized area, or even a regional area, there resides the best statistical opportunity for cure. Secondly, the cancer in question must be one that responds well to the three established therapies mentioned before in its early stages. Given this information, which treating oncologists find little argument with, I have this question. Of the billions of dollars spent annually by our government on bringing down cancer in the US, less that 2% of all money spent is applied to those areas that have historically yielded the best results – public literacy (awareness), and early detection programs. Why so little on what is so effective? While I won’t belabor the point here, consider that this is mostly controlled by doctor-scientist bureaucrats, and you can understand why solutions that are not science based, (leaving socio-economic science out of that definition) get little attention. Compared to gene therapy, early detection just doesn’t seem that exciting…. But is it something that can save lives while the search for a cure continues? Most certainly. And it should be implemented now.

So what would it take to have oral cancer, arguably the one which lends itself most readily to early detection and cure at early stages (it requires no invasive procedure, is inexpensive to look for, can be detected by the naked eye or palpation even its precancerous forms in a 3 minute exam, is easy to biopsy, and as an early stage cancer responds well to conventional therapies), depart from its more than 5 decades of no change in the death rate, to a success story like that of cervical cancer?

I began my search for an answer at the Centers for Disease Control where I have participated in the Oral Cancer Work Group for several years. After all, their charter as stated by them is: to serve as the national focus for developing and applying disease prevention and control, environmental health, health promotion and health education activities designed to improve the health of the people of the United States, and across the globe. One of CDC’s chief responsibilities is to guide and support public health practice as administered by its partner organizations. I have been told by them again and again over those years of my participation “that there is no evidence in peer reviewed publications that oral cancer screening would have any positive effect, and therefore we cannot commit to expenditures of assets towards something for which their may be no demonstrable positive effect.” My reply has always been that few are interested in spending millions on a study whose results would be self evident to anyone currently engaged in the treatment of the disease. Early staging in oral cancer statistically has been proven to yield better outcomes. Both the CDC’s and NCI’s own data document this well. Please remember that in many of the diseases like cervical cancer there was no landmark study that definitively found positive effect before it became an excepted annual screening protocol. I could make a list of CDC efforts that have been undertaken where this “proven result” criterion was not applied, but I will spare you a lengthy list.

This time when I called the head of all things dental, I thought it would be different. After all, the main roadblock as it had been presented to me, had been removed. In June 2005 a peer reviewed, long term (10 years), high population (170,000 individuals) study, published in a journal of significance (Lancet) had shown an almost 30% reduction in death rate in a group who had been screened for oral cancer vs. one which had not. When broken down by high-risk persons who smoked or engaged in other risk factors, the results were even more dramatic.

The senior dental people at the CDC, 5 months after the publication of the article, were unaware of it. Worse, having been given a couple of days to review it and revisit the issue with me, instead of embracing something which would change the paradigm of things, their first comments were to attack it. For instance, about half of the screeners in the study were not doctors, and in their mind that was a weakness. In my mind this was one of the core strengths of the article. It clearly demonstrated that it does not take a doctor, pathologist, or oncologist to recognize the early signs of oral cancers, and get these individuals started into a more sophisticated screening and treatment protocol. The end result, a comment that CDC would look into it further, but no commitment of any action or direction was made.

Next I approach individuals in the NIH. I wanted to be sure that the methodology and science in the study was sound. Of course here too I found that I had to refer people to the publication. The good news was that they agreed that there were no serious flaws in the manner which the data was collected. However, they were not in the business of setting public policy, creating recommendations, and their world was one of creating or validating the science. They did however say they would get behind an effort to replicate the study. First through a consensus conference in possibly 2006, and then via a major oral cancer conference in 2007 to help move the agenda forward. While this is at least a positive move, it seems that they missed the huge WHO conference on oral cancer in Crete this year (2005), the hundreds of oral cancer researchers, educators, and treatment professionals who attended and presented papers, and the fact that after a weeks conference of the best minds in the world on the subject, (with the US well represented in the group) that 6 out of 9 recommendations in their declaration at the conference’s end had to do with public literacy, awareness, early detection and screening programs. Do I see some of the NIH’s position as positive? Yes, when you look at the last 50-year timeline of doing less than what is possible. It does weigh on me that these are again doctor/scientist bureaucrats who do not daily personally see the toll of this disease in the patients and families involved, and the fact that repeating a conference with some uncertain outcome, say in the fall of 2007, will leave tens of thousands of newly diagnosed patients in treatment, of which only half of them will survive 5 years. I think it fairly safe to say that, that 2007 conference will not help them much.

Professional societies, and I will just single out one of several here, the ADA, since I find them to be the group most likely to embrace an opportunity to take a leadership role in bring down oral cancer from its high ranking as a killer, were lukewarm as a group. They have no standards of care for oral cancer, or many other parts of dentistry that you would think obvious, and the best they can do is make recommendations to their membership, but not enforce them. After 50 years of inactivity in the world of oral cancers, I can only fault them in a minor way. After all, they are structured and chartered to take care of their memberships needs, and that means dentists, not the American public. Personally, I think that ensuring that their membership were doing oral cancer screenings would help protect that membership from the numerous litigations for failure to diagnose, and that could easily be interpreted as helping their constituency. Yes, they do have a benevolent foundation, but oral cancer is not on the current agenda of activities. They do have an enormous amount of clout if they decide to exercise it, via state licensing boards and more, but to date that has not been a direction they have taken. They have exhibited the desire to spend the money of others in the oral cancer effort, say from a for profit product company that wishes to raise awareness of oral cancer for vested self interest, but I do not see them taking a leadership position to change the paradigm if it has to come out of their own pocket. More than that, having been told by their senior management that if the foundation aligned itself with the world of hygiene I could consider any ties or assistance (none exists to this date) to them severed, it became clear to me that turf wars were more on their agenda than a genuine desire to change the world of oral cancer.

Let’s see, whom have I not offended yet? There were calls to the state licensing boards to see if we could at least get a mandatory CE requirement for oral cancer knowledge and early detection, something that several NIH studies show is desperately needed when their peer reviewed articles showed dentist’s knowledge base needed upgrading. They referred me back to the ADA, whose current NCI 1.2 million dollar grant to increase the knowledge of dentists is in progress. While many are expressing disappointment in the preliminary results of this effort, I will withhold an opinion for now. Many of those same state licensing boards did not require the applicant to exhibit knowledge in oral cancer screening for licensure.

Lastly there were the numerous focus groups we did with dentists, doctors, and their staffs. The results of these only replicated what was previously published by the NIH, i.e. the dental community is behind the curve when it comes to being knowledgeable or engaged in the early detection of oral cancer.

All in all this was a depressing exercise. Exactly what are we asking for here? Dentistry has a well-defined referral process. A hygienist finds something that is suspect. It is referred to the general dentist for whom she works. Or a dentist finds a suspicious area and determines that it is something that he can identify or not, and that it has been there 14 days or longer without resolution. This time period does not require a recall if the patient says “I’ve had that for 4 weeks”, times up. He chooses to engage in a form of treatment or refer the patient to a specialist for a biopsy or appropriate treatment. If he begins some treatment protocol, and no resolution takes place in a short, fixed period of time, he refers the patient to someone with more oral medicine experience. That new doctor, perhaps an oral surgeon doing a biopsy, assumes control of the diagnosis and with the help of a pathologist or with an oral medicine specialist comes to a finite conclusion. Should it be something malignant, a referral outside of dentistry to the world of oncology is the next step. In this entire process, the most important part of the process are the original eyes or fingers that were involved in discovery. Without the original discovery, an oral cancer is missed and it continues to prosper into a late stage killer. No one is suggesting that hygienists or general dentists etc. become pathologists, that’s why a strong referral chain exists. But they are the key element in the system working. The first line of defense is DISCOVERY. Why this is not taking place, and 66% of oral cancer patients are found as late stage 3 and 4 cancers, indicates a breakdown of what is a very simple system. If anyone was looking and referring the questionable patients, this statistic could not exist, and in my opinion that statistical fact negates all arguments that dentistry is doing its job well. In dentistry’s defense, only 60% of the American population sees a dentist every year. Even given that statistic, there is no evidence that the other 40% make up the majority of oral cancer victims.

All this is discouraging, and while I have painted things here with a very broad brush, I will qualify it by saying that a minority of individuals in the practice of dentistry, medicine, otolaryngology and hygiene are very actively pursuing changing this paradigm seemly set in concrete. But it is far from becoming a national standard of behavior in the practicing medical/dental community, or as awareness in the public’s mind. Mine is only a single voice, but one which follows previously unheeded calls to action from editors of JADA, dental school deans, scientists at the NIDCR, and others. The American public has been failed for years on many levels, and things seem firmly embedded in the status quo. I wasn’t angry 6 years ago when my dental team and my ENT team failed to diagnose my oral cancer for months on end while it finally prospered into a late stage disease. I was just glad to survive and be on this side of the grass after treatments. Anyone can miss something, or make a mistake. Even in this litigious society, with failure to diagnose issues clearly on my side, my inclination was to try and turn that negative into a positive. But this latest exercise in trying to move a mountain of bureaucrats, find a national social responsibility in some entity who would serve the public better, an organization with a soul instead of an agenda, has left me disappointed in the institutions and individuals I have interfaced with, and yes, finally angry. Those engaged in protecting the past or maintaining the status quo hold neither the moral or scientific high ground when they allow things to continue the way they are.

Even though it is just one person’s opinion, I’d like you to think for a minute about how this opinion piece makes you feel. If it makes you feel defensive, perhaps you are on the wrong side of this issue. If you believe the situation worthy of change, why not become a proactive part of making that a reality? It’s said that a man who wishes to move a mountain starts with a handful of pebbles. I’ll be curious to see who chooses to help me pick them up, and who chooses to throw them at me.

Brian Hill is the Founder and Executive Director of The Oral Cancer Foundation (www.oralcancer.org). He is a late stage oral cancer survivor.